OCD FY2000: Letter from the Center Director

January 16, 2001

Dear Medical Device Manufacturer:

Our Fiscal Year 2000 report again has three tiers. The first is this letter, which will briefly touch on a few of the most significant CDRH activities over the past year. For those interested in more complete coverage of our programs, the next tier is a comprehensive CDRH report, which you will find on our website. That report in turn will give you access to the final tier: specific links that provide even greater detail on certain programs and activities. So you can dig as deeply and selectively as you like.

Communicating with the industry

I believe that keeping our lines of communication open and our expectations clear can help avoid needless conflict between our Center and device manufacturers. Towards that end, I’ve made a strong effort to meet with as many of you as possible over the past year, with 50 talks at industry-sponsored meetings. I’m also glad to report that many of you have communicated concerns and suggestions to me directly via e-mail (Director@cdrh.fda.gov), and I invite more of you to do this.

Good communication notwithstanding, disputes between our Center and individual manufacturers are bound to arise from time to time. To help resolve such disputes, as well as prevent them from occurring, I’ve appointed the Center’s first ombudsman, Mr. Les Weinstein, who reports directly to me. Les has already made himself known to many of you, and this process will continue in the coming year.

FDAMA

We’re now in our third year of implementing the FDA Modernization Act (FDAMA), and this continues as a high-priority effort. Over the past year we’ve expanded the list of devices eligible for third-party review, and, in concert with an industry task force, we’re working to translate the "least burdensome" provision of the law into guidance that we can use in all of our activities.

Bringing New Products to Market

"Timely decisions based on sound science" continues to be our goal in this area--a goal we think we met in FY 00. For example, our average review time for 510(k)s was the shortest in over a decade. For PMAs, our average review time was even better than last year’s, and represented a 54 percent reduction from the "peak" time registered in 1996. With IDEs, we approved a greater percentage of devices for use in clinical trials during the first 30-day cycle than in any prior year. And of course long "backlogs" remain a thing of the past throughout our premarket program.

Along with outstanding performance came new leadership. In July we welcomed Bernard E. Statland, M.D., Ph.D., as the Director of the Office of Device Evaluation. Bernie’s management team was augmented by the addition of a third deputy director, Daniel Schultz, M.D., who will work with existing deputies Phil Phillips and Kimber Richter, M.D.

Assuring Safe Products in the Marketplace

Thirty-eight manufacturers participated in our new Alternative Summary Reporting program, which allows them to submit summary adverse event reports in lieu of full reporting. In the months to come we expect that more will enroll in the program, which saves time and effort for both our Center and the industry.

We also continue to move ahead with the Medical Products Surveillance Network (MedSuN), a pilot project for gathering adverse events information that relies on in-depth information from a subset of user facilities rather than on universal reporting.

Radiological Health

Part of our Center’s mission, as embodied in its name, is to ensure the safety of radiation-emitting consumer and industrial products. Because of the need to transfer funds and personnel over the past two decades from radiological health to medical device activities, the radiological health program, which now has only 10 percent of the Center’s resources, cannot adequately do its job under the law. The situation is worsening through personnel loss, and also because changes in product technology and an increase in overseas manufacturers will require more of our attention.

We’re committed to revitalizing the radiological health program, although in the absence of significant new funding we can’t undertake major changes. Relying on ingenuity and leveraging with others, we’re exploring several possibilities, including further work with the States, training manufacturers to perform certain inspections themselves, "triaging" manufacturer reports, and making use of retired Center radiation experts.

Re-use of single-use devices

The reprocessing of single-use devices by hospitals and third parties continues to be an important issue from the standpoint of both public health and medical economics. Our goal in this area is to assure patient safety with minimum impact on health care costs. Toward this end, we issued formal guidance on our plan to enforce premarket submission requirements for third party processors and hospitals the same way we do for original equipment manufacturers. The first phase of our enforcement program will take effect in February 2001.

Strategic planning

This past year we worked hard to develop a strategy for the future-- a statement of the broad principles and goals to which we will commit ourselves over the next several years. As a first step, we re-affirmed our mission: to promote and protect the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products. Then we developed a vision: ensuring the health of the public throughout a product’s life cycle. And finally we proposed four strategic goals to fulfill the vision: (1) to apply the total product life cycle model across the Center’s activities; (2) to serve as a magnet for excellence in attracting and retaining a diverse workforce who want to help us fulfill our public health mission; (3) to manage knowledge in support of the total product life cycle model; and (4) to develop meaningful metrics to assess our continuing impact on public health and our communication with stakeholders.

A more detailed description of the Center’s strategic plan can be found at www.fda.gov/cdrh/ocd/strategic.html. I invite you to look it over and send me your comments. We’re now embarking on the first stage of implementation, and I welcome any suggestions you might have.

This has been a stimulating year, in which we addressed long-standing Center issues and confronted new challenges. For me, one of the most satisfying aspects of Fiscal Year 2000 was having the opportunity to meet with so many of you to discuss issues of common concern. I look forward to more of these exchanges.